Background: Perennial rhinitis is a common condition that affects up to 10% to 20% of the population. Multiple agents an frequently administered since no single agent provides complete relief. Studies assessing the benefit/risk of combined therapy are important especially for newly approved agents such as ipratropium bromide nasal spray 0.03%, a topical anticholinergic agent, approved specifically for the treatment of rhinorrhea in allergic and non-allergic perennial rhinitis,Objective: To compare the efficacy and safety of the combined use of ipratropium bromide nasal spray 0.03% (42 mu g per nostril tid) and beclomethasone dipropionate nasal spray (84 mu g per nostril bid) against that of either active agent alone for the treatment of rhinorrhea.Design: Multicenter, 6-week, double-blind, randomized active- and placebo-controlled, parallel trial.Setting: Allergist and general practitioner clinical practices.Patients: Five hundred thirty-three patients with perennial rhinitis (279 allergic and 274 non-allergic), 8 to 75 years of age, who had at least a mild degree of severity of rhinorrhea for a minimum of 2 hours per day during the I week screening period as well as congestion or sneezing also of at least mild severity.Intervention: Either (1) ipratropium bromide nasal spray 0.03% (42 mu g per nostril tid) plus beclomethasone dipropionate nasal spray (84 mu g per nostril bid), (2) ipratropium bromide nasal spray 0.03% (42 mu g per nostril tid) alone, (3) beclomethasone dipropionate nasal spray (84 mu g per nostril bid) alone, or (4) vehicle [matching placebo nasal spray for the ipratropium bromide (2 sprays per nostril tid)] or beclomethasone dipropionate (2 sprays per nostril bid).Main Outcome Measure: Severity and duration of rhinorrhea, and patient and physician global assessment of control of rhinorrhea. Results: Ipratropium bromide nasal spray plus beclomethasone nasal spray was more effective than either active agent alone or vehicle in reducing the average severity and duration of rhinorrhea during 4 weeks of treatment. The advantage of ipratropium bromide plus beclomethasone nasal spray was evident by the first day of combined treatment and continued throughout the 2-week treatment period. Ipratropium bromide nasal spray had a faster onset of action during the first week of treatment and reduced the duration of rhinorrhea more than beclomethasone. Beclomethasone nasal spray was more effective in reducing the severity of congestion and sneezing than ipratropium. Tn patients who had not responded well to a nasal steroid prior to participation in the study based on a questionnaire administered at screening, ipratropium bromide was as effective in the steroid non-responders as steroid responders, whereas beclomethasone was more effective in steroid responders. Combined active therapy was well tolerated with no increase in adverse events over that seen previously with ipratropium bromide or beclomethasone nasal spray alone.Conclusions: The combined use of ipratropium bromide nasal spray with beclomethasone dipropionate nasal spray is more effective than either active agent for treatment of rhinorrhea, and does not result in a potentiation of adverse drug reactions. Ipratropium bromide nasal spray 0.03% alone should be considered in patients for whom rhinorrhea is the primary symptom, and its use in combination with a nasal steroid should be considered in patients where rhinorrhea is one of the predominant symptoms, or in patients with rhinorrhea not fully responsive to other therapy.

To determine the relative efficacy, compare the incidence of adverse events, and ascertain the systemic glucocorticoid effect of the nasal application of several doses of budesonide, 406 patients with seasonal ragweed-induced allergic rhinitis were randomized in a double-blind, parallel group design to receive intranasal budesonide aqueous pump spray (Rhinocort Aqua) 32 micrograms, 64 micrograms, 128 micrograms, 256 micrograms, or placebo once daily for 4 weeks. A total of 231 adults and 175 children participated in the study conducted at 14 centers in two geographic regions, the Midwest and the Northeast United States, during the 1994 ragweed season. Pollen counts were collected at each site by the Rotorod method. The primary efficacy parameter was the change from baseline nasal index score (NIS) for the overall study population--defined as the sum of scores for nasal congestion, runny nose, and sneezing. The study was powered only to evaluate the overall study population for statistical significance. Significant differences in NIS were observed in each active treatment group compared with placebo (p < or = 0.003). Compared with placebo, budesonide aqueous spray significantly reduced individual symptoms of runny nose and sneezing at all doses (p < or = 0.008), and nasal congestion and nasal itching at all doses except 64 micrograms (p < or = 0.022). In the Midwest pollen belt where the 1994 ragweed season was representative of a typical pollen season, it was possible to establish a dose-response relationship for comparison of budesonide aqueous spray 256 micrograms versus 32 micrograms (p = 0.017). The incidence of adverse events was similar between budesonide aqueous-treated and placebo-treated patients. Importantly, there was no effect of budesonide aqueous spray on basal or ACTH-stimulated plasma cortisol levels in either adults or children at the end of 4 weeks of treatment. Intranasal budesonide aqueous pump spray, administered once daily, was efficacious and was generally well tolerated in both adults and children with seasonal allergic rhinitis.

Medical treatment of perennial rhinitis is aimed at providing symptomatic relief of individual symptoms. Multiple agents are administered when no single agent provides complete relief. Studies assessing the benefit/risk of combined therapy are important, especially for newly available agents such as ipratropium bromide nasal spray, a topical anticholinergic agent approved for the treatment of rhinorrhea in allergic and nonallergic perennial rhinitis. The objective was to determine whether the combined use of ipratropium bromide nasal spray 0.03% (42 mcg per nostril) administered three times daily with a nonsedating antihistamine (terfenadine, 60 mg administered twice daily) is safe and provides greater clinical benefit than use of the placebo nasal spray plus terfenadine. Our method was a multicenter, 6-week, double-blind, randomized, active-controlled, crossover trial of 205 patients with perennial rhinitis (114 allergic and 91 nonallergic), 18 to 75 years of age, who had clinically significant rhinorrhea. After a 1-week run-in period, patients were treated for 2 weeks with one of the two treatment regimens, followed by a 1-week washout period, and then were treated for another 2 weeks with the other treatment regimen. Daily diary symptoms scores of rhinorrhea, congestion, and sneezing were obtained, as well as biweekly patient and physician global assessments of treatment effectiveness of each of the nasal symptoms. Ipratropium bromide nasal spray plus terfenadine was more effective than vehicle plus terfenadine in reducing the average severity (38% versus 28%) and duration (46% versus 30%) of rhinorrhea during the 2 weeks of treatment from baseline (p < 0.05). The advantage of ipratropium bromide nasal spray plus terfenadine was evident by the second day of treatment and continued throughout the 2-week treatment period. Of patients who responded more to one treatment than another, 69% responded to ipratropium bromide nasal spray plus terfenadine, compared to 31% to vehicle plus terfenadine (p < 0.05). Both physicians and patients rated control of rhinorrhea and sneezing by ipratropium bromide nasal spray plus terfenadine as superior to vehicle plus terfenadine (p < 0.05). The symptom of congestion was controlled equally well by both treatments. Combined active therapy was well tolerated with no increase in adverse events over that seen previously with ipratropium bromide nasal spray alone. The combination of ipratropium bromide nasal spray with terfenadine is more effective than vehicle plus terfenadine for the treatment of rhinorrhea, and does not result in a potentiation of adverse drug reactions.

Triamcinolone acetonide (TAA) Aqueous nasal inhaler is an effective and well-tolerated treatment for the symptoms associated with seasonal allergic rhinitis (SAR). This study compared the safety and efficacy of once-daily administration of TAA Aqueous nasal inhaler (110 mu g and 220 mu g) with placebo in a pediatric population with spring-grass SAR. Two hundred and twenty-three patients (6-11 years of age) were evaluated in this randomized, placebo-controlled, double-blinded trial. Patients received TAA Aqueous nasal inhaler (110 mu g or 220 mu g) or placebo once daily for 2 weeks. Rhinitis symptoms (nasal stuffiness, discharge, sneezing, nasal index, nasal itching, and eye symptoms) mere evaluated and recorded daily. Both TAA Aqueous nasal inhaler dosages were more effective than placebo in relieving the symptoms of SAR over the 2-week treatment period. Patients in the 110-mu g group had significantly (P < 0.05) greater mean reductions in nasal stuffiness, nasal discharge, and nasal index compared to placebo after week 1, week 2, and overall. Patients who received TAA Aqueous nasal inhaler 220 mu g had significantly (P < 0.05) larger mean reductions in nasal stuffiness after week 1, week 2, and overall, compared to placebo, with significant (P 0.034) improvements in nasal stuffiness as early as day 1. Patient and physician satisfaction effects with both TAA Aqueous nasal inhaler regimens was low and comparable with placebo. This double-blinded, placebo-controlled trial demonstrated that TAA Aqueous nasal inhaler (110 mu g and 220 mu g per day) was well tolerated and reduced spring grass SAR symptoms significantly in children. (Pediatr Asthma Allergy Immunol 1997;11[2]:129-136.)

Objective: This study explored the safety and efficacy of cetirizine for treatment of allergic rhinitis and asthma.Methods: Daily treatment for 6 weeks with cetirizine 10 mg (93 patients) was compared with placebo treatment(93 patients) in a randomized, double-blind parallel study of patients with allergic rhinitis and asthma. This multicenter study was started just-before onset of the fall pollen season. Rhinitis and asthma symptoms were assessed twice daily; spirometry was performed weekly.Results: Placebo-treated patients experienced a worsening of rhinitis symptoms from baseline throughout the study, whereas cetirizine-treated patients had a significant improvement in rhinitis symptoms at week I, which was maintained after onset of the pollen season. Asthma symptoms in the cetirizine group improved from baseline at week 1; symptoms were significantly better than in the placebo group for 5 of 6 weeks of the study. Pulmonary function did not worsen in patients taking cetirizine or placebo; there were no differences between treatments as determined by spirometry. Albuterol use was less frequent in the cetirizine-treated patients for every week of the study but differences did not reach significance. Pseudoephedrine use was similar in both groups. More cetirizine-treated patients (90%) completed the trial than did placebo-treated patients (74%). Both treatments were well tolerated.Conclusion: Cetirizine 10 mg daily is safe;and effective in relieving both upper and lower respiratory tract symptoms in patients with seasonal allergic rhinitis and concomitant asthma.

Because some patients may prefer aqueous nasal sprays and once-daily dosing for relief of seasonal allergic rhinitis symptoms, a new aqueous formulation of triamcinolone acetonide (TAA Aqueous) was developed. We conducted a randomized, placebo-controlled, double-blind study to compare the efficacy and safety of once-daily administration of 220 μg/d of TAA Aqueous for 1 week, followed by either 220 μg/d or 110 μg/d for an additional 2 weeks, with that of placebo in 429 patients with seasonal allergic rhinitis. Patients recorded the severity of symptoms (nasal stuffiness, discharge, sneezing, nasal index [the sum of the first three variables], nasal itching, and eye symptoms) on daily diary cards. Patients' and physicians' global evaluations of efficacy were made at the end of the 3-week study period. Both regimens of TAA Aqueous significantly improved symptoms compared with placebo at most time points. Patients demonstrated significant improvements in nasal symptoms as early as the first day of treatment (within 12 to 16 hours based on treatment in the morning and symptom assessment at bedtime). Although TAA Aqueous 220 μg/d provided numerically greater reductions in nasal symptoms compared with 110 μg/d, these differences in efficacy over the last 2 weeks were not statistically significant. The incidence of adverse effects with both TAA Aqueous regimens was low and comparable to that of placebo. In summary, during the first week of therapy, TAA Aqueous 220 μg/d significantly reduced nasal symptoms. During the last 2 weeks of therapy, the 110 μg/d regimen of TAA Aqueous was effective as continued therapy for most patients. Both the 110 μg/d and 220 μg/d regimens of TAA Aqueous provided significantly better relief of nasal symptoms than did placebo.